Approximately 300,000 patients undergo hemodialysis in the United States alone, with approximately 100,000 new hemodialysis patients being added each year. In order to perform hemodialysis, vascular access to the patient's blood stream is required. Currently, the options for permanent hemodialysis access are fistulas and grafts, which generally speaking are abnormal connections made between a peripheral artery and vein. Such connections essentially bypass the capillary system, thereby providing the larger flow rates required for hemodialysis. However, the life span of grafts and fistulas are low: 3 to 4 years for fistulas and 1.5 years for grafts.
Also, these connections require many interventions during their lifespan, which not only increases morbidity, but also adds large costs to the healthcare system. The failure of these connections is related to the development of stenosis due to constant large flow rates. After, repeated surgeries an access site will fail and a new access site is used until no access sites are left. A lack of remaining access sites accounts for 18% of hemodialysis patient mortality. In addition, innovation related to vascular access for hemodialysis has focused on incremental improvements to grafts and catheters, with little to no development of alternative methods and devices.
It would therefore be advantageous to provide a valve to facilitate hemodialysis that does not require the connection of an artery and vein using a graft or fistula.